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Sodium Thiosulfate for Chemotherapy-Induced Hearing Loss

Phase < 1
Recruiting
Led By James Geller, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients may not be enrolled on another clinical trial or receiving any other investigational therapies (within 2 weeks prior to study enrollment)
Histologically proven hepatoblastoma, Wilms tumor, Germ Cell Tumor, or Neuroblastoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion up to 5 years
Awards & highlights

Study Summary

This trial will test a drug (Sodium Thiosulfate) to see if it can prevent hearing loss from chemotherapy. #medicaltrial

Who is the study for?
This trial is for patients aged 1 month to 39 years with hepatoblastoma or certain other cancers, who have previously responded to cisplatin but now show progression or resistance. They must have a life expectancy of at least 8 weeks, good organ function, and no severe side effects from previous treatments. Pregnant women and those with heart failure or uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Sodium Thiosulfate (STS) in preventing hearing loss when given alongside cisplatin-based chemotherapy. There are two regimens: CS (Cisplatin/STS) for those previously sensitive to cisplatin, and CSS (Cisplatin/STS/Vorinostat) for those who've shown progression on or resistance to cisplatin.See study design
What are the potential side effects?
Potential side effects include allergic reactions to treatment components, issues related to bone marrow suppression like low blood counts, liver problems indicated by abnormal bilirubin and enzyme levels, kidney dysfunction measured by creatinine clearance rates, and possibly worsening of pre-existing hearing loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently in another clinical trial or taking experimental treatments.
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My cancer is one of the following types: hepatoblastoma, Wilms tumor, germ cell tumor, or neuroblastoma.
Select...
My liver tests are within the required range.
Select...
My kidneys work well enough (GFR > 30).
Select...
I am between 1 month and 39 years old.
Select...
My blood tests show enough white cells, platelets, and hemoglobin.
Select...
I have recovered from side effects of my previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevention of hearing loss
Secondary outcome measures
Maximum Plasma Concentration [Cmax]
Number of Participants with Treatment-Related Adverse Events
Prevention of hearing loss and tumor reduction
+2 more

Side effects data

From 2023 Phase 2 & 3 trial • 15 Patients • NCT03267277
100%
Flow cytometry
100%
Venous oxygen saturation decreased
100%
Systolic hypertension
100%
Hypertension
100%
Venous oxygen saturation increased
93%
Hyperglycemia
93%
Red blood cell count decreased
93%
Urine protein, quantitative increased
93%
Urine sodium increased
93%
Hypokalemia
93%
Hyponatremia
93%
Immature granulocyte percentage increased
93%
Blood chloride increased
93%
Blood lactate dehydrogenase increased
93%
Anemia
93%
Diastolic hypotension
93%
Creatinine urine decreased
86%
Urine analysis abnormal
86%
Red cell distribution width increased
86%
Coagulation factor VIII level increased
86%
Urine magnesium decreased
86%
White blood cells urine increased
86%
Urine protein/creatinine ratio increased
79%
Blood bicarbonate increased
79%
PO2 increased
79%
Mean cell hemoglobin concentration decreased
79%
PCO2 decreased
79%
Carbon dioxide decreased
79%
Blood bicarbonate decreased
71%
Blood immunoglobulin G increased
71%
Urine phosphorus decreased
71%
Hypocalcemia
71%
Blood albumin decreased
71%
Urine ketone body present
71%
Immature granulocyte count increased
71%
Red blood cells urine increased
71%
Creatinine renal clearance decreased
71%
Venous blood pH decreased
71%
Vitamin D decreased
64%
Sinus tachycardia
64%
Calcium ionized decreased
64%
Creatinine urine increased
64%
Reticulocyte percentage increased
64%
Ionized Magnesium decreased
64%
Blood creatinine decreased
64%
Ionized Magnesium increased
64%
Lymphocyte percentage increased
64%
C-reactive protein-high sensitivity increased
64%
Hypoglycemia
57%
Cystatin C increased
57%
Urine leukocyte esterase positive
57%
Eosinophil count decreased
57%
Red blood cell sedimentation rate increased
57%
Reticulocyte hemoglobin equivalent
50%
Basophil percentage increased
50%
Blood phosphorus decreased
50%
Transferrin saturation decreased
50%
Erythroblast count increased
50%
Serum ferritin increased
50%
Urine potassium decreased
50%
Nausea
50%
Blood urea nitrogen decreased
50%
Neutrophil percentage decreased
50%
Glucose urine present
50%
Absolute neutrophil count increased
50%
Urine magnesium increased
43%
Blood phosphorus increased
43%
Antinuclear antibody increased
43%
Blood immunoglobulin E increased
43%
Blood iron decreased
43%
Neutrophil percentage increased
43%
White blood cell count increased
43%
Blood parathyroid hormone increased
43%
Basophil count increased
43%
Protein total increased
43%
Monocyte percentage decreased
43%
Eosinophil percentage decreased
43%
Mean platelet volume decreased
43%
Activated partial thromboplastin time shortened
43%
Reticulocyte count increased
43%
Hypomagnesemia
43%
Hypotension
43%
Lymphocyte percentage decreased
43%
Blood creatine phosphokinase increased
43%
Von Willebrand's factor activity increased
43%
Urine oxalate decreased
43%
Hemoglobin urine present
43%
Alanine aminotransferase increased
43%
Urine phosphorus increased
43%
Fibroblast growth factor 23 increased
36%
Anion gap decreased
36%
Blood insulin increased
36%
Urine calcium decreased
36%
Headache
36%
Blood erythropoietin increased
36%
Brain natriuretic peptide increased
36%
Diastolic hypertension
36%
Blood immunoglobulin A increased
36%
Aspartate aminotransferase increased
36%
Citric acid urine decreased
36%
Protein urine present
36%
Absolute lymphocyte count increased
36%
Platelet count decreased
36%
Blood thyroid stimulating hormone increased
36%
Anion gap increased
29%
Blood alkaline phosphatase decreased
29%
Blood creatine phosphokinase MB increased
29%
Blood uric acid increased
29%
Calcium ionized increased
29%
Urinary casts present
29%
Absolute neutrophil count decreased
29%
Absolute monocyte count increased
29%
Aldolase increased
29%
Blood chloride decreased
29%
Von Willebrand's factor antigen increased
29%
Urine uric acid increased
29%
Eosinophil percentage increased
29%
Absolute monocyte count decreased
29%
Myelocyte percentage increased
29%
White blood cell count decreased
29%
Protein total decreased
29%
Sinus bradycardia
29%
Pain in extremity
29%
Abnormal clotting factor
21%
Basophil percentage decreased
21%
PO2 decreased
21%
Hypernatremia
21%
Creatinine renal clearance increased
21%
Corona virus infection
21%
Glycosylated hemoglobin increased
21%
Human T-cell lymphotropic virus infection
21%
Basophil count decreased
21%
Blood immunoglobulin M decreased
21%
Urine calcium increased
21%
Activated partial thromboplastin time prolonged
21%
Antinuclear antibody positive
21%
Hepatitis B surface antigen positive
21%
Hepatitis B core antibody positive
21%
Blood triglycerides increased
21%
Monocyte percentage increased
14%
Thyroxine free decreased
14%
Catheter site infection
14%
Anisocytosis
14%
Hyperthermia
14%
Blood cholesterol increased
14%
Vitamin B12 increased
14%
Vitamin D increased
14%
Blood magnesium increased
14%
Blood thyroid stimulating hormone decreased
14%
Metamyelocyte percentage increased
14%
Urine sodium decreased
14%
Urine uric acid decreased
14%
Hypercalcemia
14%
Insulin C-peptide increased
14%
Platelet count increased
14%
Prothrombin time prolonged
14%
Red blood cell morphology abnormal
14%
Specific gravity urine increased
14%
Transferrin decreased
14%
Nitrite urine present
14%
Urine albumin/creatinine ratio increased
14%
Blood folate increased
14%
Urine calcium oxalate
14%
Autoantibody positive
14%
Absolute lymphocyte count decreased
14%
Mean cell hemoglobin decreased
14%
Dental caries
14%
Urobilinogen urine
7%
Device related infection
7%
Lymphocyte count decreased
7%
Blood urea nitrogen increased
7%
Epstein-Barr virus infection
7%
Hepatitis viral
7%
Anion gap
7%
Blood homocysteine increased
7%
Blood immunoglobulin D increased
7%
Blood parathyroid hormone
7%
Haptoglobin decreased
7%
Low density lipoprotein abnormal
7%
PCO2 increased
7%
Platelet morphology abnormal
7%
Promyelocyte count increased
7%
Red blood cell microcytes present
7%
Serum ferritin decreased
7%
T-lymphocyte count increased
7%
Transferrin saturation increased
7%
Urine oxalate increased
7%
Hyperuricemia
7%
Anxiety
7%
Blister
7%
Blood calcium decreased
7%
Blood creatinine increased
7%
Blood glucose increased
7%
Laboratory test
7%
Thyroxine decreased
7%
Venous blood pH increased
7%
Mean cell volume decreased
7%
Blood parathyroid hormone decreased
7%
Wound infection staphylococcal
7%
Foreign body
7%
Hemoglobin decreased
7%
Eosinophil count increased
7%
Mean cell volume increased
7%
Pruritus
7%
Nephrolithiasis
7%
Procedural dizziness
7%
Fibrin D dimer increased
7%
Drug level above therapeutic
7%
Bilirubin urine present
7%
Aspartate aminotransferase
7%
Aspartate aminotransferase decreased
7%
Bilirubin conjugated
7%
Urea renal clearance decreased
7%
Carbon dioxide increased
7%
Blood bilirubin increased
7%
Electrophoresis protein abnormal
7%
Beta 2 microglobulin urine increased
7%
Neutrophil count decreased
7%
Transferrin increased
7%
Red blood cell poikilocytes present
7%
Albumin urine present
7%
Urine potassium increased
7%
Migraine
7%
Vomiting
7%
Urine amino acid level abnormal
7%
Cystatin C abnormal
7%
Alanine aminotransferase
7%
Blood creatine phosphokinase decreased
7%
Haptoglobin increased
7%
Prothrombin time shortened
7%
Nasal congestion
7%
Red blood cell sedimentation rate
7%
pH urine increased
7%
Mean cell hemoglobin increased
7%
Lipids abnormal
7%
Citric acid urine increased
7%
Blood bilirubin decreased
7%
Blood iron increased
7%
Reticulocyte count decreased
7%
Hyperkalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stratum 2B- Regimen CSSExperimental Treatment1 Intervention
Wilms tumor, GCT, Neuroblastoma
Group II: Stratum 2A- Regimen CSSExperimental Treatment1 Intervention
Cisplatin resistant or progressed on cisplatin after initial response (when given at first diagnosis)
Group III: Stratum 1- Regimen CSExperimental Treatment1 Intervention
Cisplatin sensitive/no progression on cisplatin (when given at first diagnosis)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2014
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
814 Previous Clinical Trials
6,531,548 Total Patients Enrolled
James Geller, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
1,087 Total Patients Enrolled

Media Library

Stratum 1- Regimen CS Clinical Trial Eligibility Overview. Trial Name: NCT05756660 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for enlistment in this clinical experimentation?

"To partake in this clinical trial, prospective patients must have ototoxicity from a drug-based cause and be between 1 month and 39 years old. Currently, 33 people are being recruited for the study."

Answered by AI

Are there any remaining vacancies for those interested in participating within this trial?

"Affirmative. According to clinicaltrials.gov, this experimental research is currently searching for volunteers; it was first published on March 1st 2023 and most recently updated on the 2nd of that same month. The team seeks 33 participants from a single facility."

Answered by AI

How extensive is the participant pool of this research experiment?

"Affirmative. The clinicaltrials.gov website exhibits that this trial, which was initially listed on March 1st 2023, is actively recruiting participants. 33 individuals are needed to participate from a single medical site."

Answered by AI

Is the age requirement for this trial flexible enough to accept participants aged 70 and over?

"The requirements to become a participant in this research include being between 1 Month and 39 years old. 32 trials are available for minors, while 15 focus on elderly individuals."

Answered by AI
~13 spots leftby Jan 2025